The Association of Clinical Research Professionals

Informed Consent Simulation

This interactive, simulation-powered training program helps ensure informed consent is obtained by the right subject, with the right forms, by the right people, through the right process, at the right time, and with the right documentation.

By playing the roles of patient, study coordinator, investigator, sub-investigator, and study monitor/CRA in a variety of simulated scenarios, course participants gain a 360-degree understanding of informed consent principles while practicing application of associated competencies.

Through cutting-edge adaptive learning, this program moves clinical research professionals of all types far beyond merely learning about the historical context, regulatory requirements, and theory of informed consent to actually developing and practicing the competencies required for proper informed consent.

Applicable for both site teams and monitors/CRAs working on behalf of study sponsors and CROs, this program provides a comprehensive view of the informed consent process and includes applicable regulatory guidelines including ICH GCP and the Declaration of Helsinki and info sheets and guidelines from the U.S. Food and Drug Administration and the World Health Organization.

At the end of this course, participants should be able to:

  • Describe the elements that constitute a compliant informed consent process
  • Explain the theory as well as best practices for obtaining and documenting informed consent with clinical research participants
  • List the core competencies required of clinical research professionals to properly conduct and document the informed consent process

This course is applicable for anyone working in clinical research who is responsible for conducting, documenting, and/or verifying that informed consent was obtain properly — specifically, Principal Investigators, Sub-Investigators, CRCs, CRAs, and Clinical Trial Assistants.

Approved for 2.0 ACRP Contact Hours | Available 1 Year from Enrollment Date